Breast CancerPhase 2NCT01038908
Breast Lymph Node Mapping
A Phase 2 study testing Isosulfan Blue (Patent Blue Dye V) in people with Breast Cancer, run by University of British Columbia at 2 sites in Canada.
Trial summary
The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue dye and the breast drainage system with a radioactive material. By identifying the arm lymphatics they can be protected during surgery and this may decrease the occurrence of lymphedema. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Isosulfan Blue (Patent Blue Dye V)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19-100 years old
- Not pregnant or breastfeeding
- Breast cancer requiring LN evaluation for the breast
- Willing participation following an informed consent process
Who cannot join
- Patient < 19 y/o or > 100 y/o
- Pregnant or breastfeeding
- Allergy to blue dye
- Locally advanced axillary disease
- History of receiving neoadjuvant chemotherapy treatment
- Prior axillary surgery or radiation therapy
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Mount Saint Joseph's Hospital
Vancouver, British Columbia
Sam Wiseman, MD, FRCSC, FACS, 604-806-9108, smwiseman@providencehealth.bc.ca
St. Paul's Hospital
Vancouver, British Columbia
Sam Wiseman, MD, FRCSC, FACS, 604-806-9108, smwiseman@providencehealth.bc.ca
About this study
Official title: Axillary Reverse Mapping in Breast Cancer
The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue dye and the breast drainage system with a radioactive material. By identifying the arm lymphatics they can be protected during surgery and this may decrease the occurrence of lymphedema. The information obtained in this study may provide us with better surgical techniques to identify and protect the arm lymphatic drainage system in the axilla.
Read the detailed description
This study is a non-randomized Phase II study of the Axillary Reverse Mapping (ARM) procedure for patients presenting with breast cancer requiring lymph node evaluation. The study will enroll 100 subjects, and will have two study arms: one for patients requiring only the SLNB procedure (roughly 67% of enrollees), and one for patients requiring a full ALND (roughly 33% of enrollees). For the analysis of study efficacy, each arm will be compared to its procedure-appropriate historical control for evidence of decrease in the 1-year lymphedema rate among patients undergoing SLNB or ALND.
Additional data will be collected on the treatment population's (a) variability in location of arm lymphatics, and (b) incidence of SLN crossover with arm lymphatics, along with success-rate data for identifying SLNs and arm lymphatics during SLNB and/or ALND. This additional data will add to our level of knowledge and experience regarding lymph node surgery.
- Conditions
- Breast Cancer
- Being tested
- Isosulfan Blue (Patent Blue Dye V)
- Keywords
- sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), lymphatics, blue dye
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosulfan Blue (Patent Blue Dye V)Other
- Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe
- Pre-incision: SLN is identified
- Inject blue dye into patient's arm
- Complete procedure (SLNB and/or ALND)
Isosulfan Blue (Patent Blue Dye V)Other
- Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe
- Pre-incision: SLN is not identified (No localization)
- Inject blue dye into breast (nothing in arm)
- No localization: Inject blue dye into arm and perform ALND ii. Localization: Complete procedure (SLNB and/or ALND)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol. Receives: Other: Isosulfan Blue (Patent Blue Dye V) |
| 2 | Active comparator | Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol. Receives: Other: Isosulfan Blue (Patent Blue Dye V) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Map arm lymphatic drainage system in the axilla
Measured: 4 years
Secondary outcomes (1)
Decrease the occurrence of lymphedema
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startJun 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Wiseman, MD, FRCSC, FACS, Principal investigator, University of British ColumbiaUrve Kuusk, MD, FRCSC, Study director, University of British ColumbiaCarolyne Dingee, MD,FRCSC, Study director, University of British ColumbiaElaine McKevitt, MD, FRCSC, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038908
- Sponsor's protocol ID
- H09-00926
- Status last verified
- Feb 2013
- First submitted
- 22 Dec 2009
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Reverse Mapping in Breast Cancer
- ClinicalTrials.gov ID
- NCT01038908
- Acronym / sponsor ID
- H09-00926
- Conditions
- Breast Cancer
- Keywords
- sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), lymphatics, blue dye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue dye and the breast drainage system with a radioactive material. By identifying the arm lymphatics they can be protected during surgery and this may decrease the occurrence of lymphedema. The information obtained in this study may provide us with better surgical techniques to identify and protect the arm lymphatic drainage system in the axilla.
Detailed description
This study is a non-randomized Phase II study of the Axillary Reverse Mapping (ARM) procedure for patients presenting with breast cancer requiring lymph node evaluation. The study will enroll 100 subjects, and will have two study arms: one for patients requiring only the SLNB procedure (roughly 67% of enrollees), and one for patients requiring a full ALND (roughly 33% of enrollees). For the analysis of study efficacy, each arm will be compared to its procedure-appropriate historical control for evidence of decrease in the 1-year lymphedema rate among patients undergoing SLNB or ALND.
Additional data will be collected on the treatment population's (a) variability in location of arm lymphatics, and (b) incidence of SLN crossover with arm lymphatics, along with success-rate data for identifying SLNs and arm lymphatics during SLNB and/or ALND. This additional data will add to our level of knowledge and experience regarding lymph node surgery.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Isosulfan Blue (Patent Blue Dye V)Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol. |
| 2 | Active comparator | Other: Isosulfan Blue (Patent Blue Dye V)Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 19-100 years old
- Not pregnant or breastfeeding
- Breast cancer requiring LN evaluation for the breast
- Willing participation following an informed consent process
Key exclusion criteria (6 listed)
- Patient < 19 y/o or > 100 y/o
- Pregnant or breastfeeding
- Allergy to blue dye
- Locally advanced axillary disease
- History of receiving neoadjuvant chemotherapy treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isosulfan Blue (Patent Blue Dye V)1. Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe 2. Pre-incision: SLN is identified 3. Inject blue dye into patient's arm 4. Complete procedure (SLNB and/or ALND) | Other | 1 |
| Isosulfan Blue (Patent Blue Dye V)1. Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe 2. Pre-incision: SLN is not identified (No localization) 3. Inject blue dye into breast (nothing in arm) i. No localization: Inject blue dye into arm and perform ALND ii. Localization: Complete procedure (SLNB and/or ALND) | Other | 2 |
Primary outcome
Map arm lymphatic drainage system in the axilla
Time frame: 4 years
1 secondary outcome
Decrease the occurrence of lymphedema
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Wiseman, MD, FRCSC, FACS principal investigator
University of British Columbia
Urve Kuusk, MD, FRCSC study director
University of British Columbia
Carolyne Dingee, MD,FRCSC study director
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isosulfan Blue (Patent Blue Dye V) in people with Breast Cancer, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam Wiseman, MD, FRCSC, FACS (604-806-9108, smwiseman@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Map arm lymphatic drainage system in the axilla (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.